DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Aveda Corporation, Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium dioxide 6.3%	Sunscreen
Zinc oxide 4.1%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well. apply generously 15 minutes before sun exposure
• for sunscreen use, reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

Water\Aqua\Eau, Dimethicone, Dicaprylyl Carbonate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Propanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Aleurites Moluccana (Kukui) Seed Oil, Trimethylsiloxysilicate, Silica, Hydrogenated Castor Oil/Sebacic Acid Copolymer, Rosmarinus Officinalis (Rosemary) Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Caffeine, Punica Granatum (Pomegranate) Extract, Polygonum Cuspidatum, Root Extract, Zingiber Officinale (Ginger) Root Extract, Vanilla Planifolia Fruit Extract, Oryzanol, Ascorbyl Palmitate, Hydroxyapatite, Dimethicone Silylate, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Dimethicone/Polyglycerin-3 Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Caprylyl Glycol, Phenoxyethanol <ILN41846>

Other Information

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

AVEDA
THE ART AND SCIENCE OF PURE
FLOWER AND PLANT ESSENCES

daily light
guard™

defense fluid
broad spectrum
SPF 30

1 fl oz/oz liq/30 ml e

INGREDIENTS AND APPEARANCE

DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57677-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65.85 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42.85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)
Propanediol (UNII: 5965N8W85T)
Dipentaerythrityl Tri-Polyhydroxystearate (UNII: D21K655H52)
Kukui Nut Oil (UNII: TP11QR7B8R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Rosemary (UNII: IJ67X351P9)
Sunflower Oil (UNII: 3W1JG795YI)
Tocopherol (UNII: R0ZB2556P8)
Caffeine (UNII: 3G6A5W338E)
Pomegranate (UNII: 56687D1Z4D)
Reynoutria Japonica Root (UNII: 7TRV45YZF7)
Ginger (UNII: C5529G5JPQ)
Vanilla (UNII: Q74T35078H)
Gamma Oryzanol (UNII: SST9XCL51M)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57677-063-01	1 in 1 CARTON	05/01/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/01/2016

Labeler - AVEDA COPORATION (071352058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(57677-063) , REPACK(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(57677-063) , REPACK(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(57677-063) , REPACK(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(57677-063)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(57677-063)